HSA is essentially synthesized by the liver, and is an important material transport carrier in the blood, and based on the characteristic that it has no obvious immunogenicity, the HSA can be used as carrier protein that improves the half life of drugs.
In applications of the prior art, the HSA can be used along with small molecule drugs, to serve as a carrier that transports and releases drugs. Binding of the HSA and the small molecule drugs can increase solubility of the drugs in plasma, reduce toxicity and avoid oxidization, thereby increasing the half life of treatment of the small molecule drugs in the body of an individual. However, too strong binding of the HSA and the small molecule drugs may also affect release effects in target tissues of the drugs.
The prior art, in order to improve the defects of the HSA carrier, further prepares the albumin into nanoparticles through a nanotechnology, to make it have better stability, longer storage life and a wider range of applications. The advantage of preparing the albumin into nanoparticles lies in that it can encapsulate and transfer cancer drugs with low solubility. For example, at present, an albumin bonding Abraxane nanoparticle (Abraxane®) has existed, and the average particle size of the nanoparticle is about 130 nm. The US FDA approved in 2006 that Abraxane® can be applied to metastatic breast cancer patients ineffective or relapsed for other therapeutic drugs, and in 2012, the US FDA approved once again that the drug can be applied to treatment of patients with non-small cell lung cancer. The albumin nanoparticle can accumulate drugs to tumor sites by means of Enhanced Permeability and Retention effect. At the same time, the particle can be transferred to the tumor by means of a 60 kDa glycoprotein (gp60) receptor (albondin) with selective over-expression. In addition, it is pointed out according to the study that the albumin nanoparticle can carry out transcytosis by means of receptors in cancer cells, and is bonded to secreted protein acidic rich in cysteine (SPARC) on the surface of cancerous cells. Based on the aforementioned three mechanisms of action, Abraxane® has lower toxicity compared with the traditional chemotherapy drug Taxol and can shorten drug administration time and have better therapeutic effects. However, stability of such an albumin nanoparticle is not good, and stability can only be maintained for 2-8 hours when the albumin nanoparticle is dispersed in a 0.9% sodium chloride solution, which still has limitations to clinical applications.
In addition, it should be noted that in current manufacturing of albumin nanoparticles identical with or similar to Abraxane®, during preparation, poisonous substances such as trichloromethane or dichloromethane may be used, the preparation procedure is tedious and spends a lot of time, thus increasing the cost of production, and the nanoparticle made with such steps has a potential risk of being contaminated with toxic substances.
In view of this, there is an urgent need for an improved nanoparticle and a method for manufacturing the same in the field, so as to improve the shortcomings of the prior art.